Rethinking the Validation Process for Medical Devices: A Cardiac Pacemaker Case Study

Author(s):  
Sidharta Andalam ◽  
Partha Roop ◽  
Avinash Malik ◽  
Mark Trew
Author(s):  
Ellen J. Bass ◽  
Justine S. Sefcik ◽  
Elease McLaurin ◽  
Rose Ann DiMaria-Ghalili

A prototype medical device and protocol that work well in a clinic would not necessarily work reliably in the home setting. The goal of this work is to identify factors to consider when translating a device evaluated in a clinic for use by home caregivers providing chronic wound care for persons living with dementia. One must consider the current device, the associated bundle, the protocol and how they may need to be modified. Semi-structured interviews with the research assistants who have applied a prototype device were conducted to generate a list of known issues with the current clinical protocol in terms of ultrasound application The researchers performed a set of specified tasks by following the current device protocol and explaining any difficulties with use\execution. They embellished the descriptions with details about what had happened with actual patients in the clinic. Using thematic analysis, analysts identified themes and subthemes. Issues potentially relevant to translating medical devices to the home are discussed.


2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Hanjun Ryu ◽  
Hyun-moon Park ◽  
Moo-Kang Kim ◽  
Bosung Kim ◽  
Hyoun Seok Myoung ◽  
...  

AbstractSelf-powered implantable devices have the potential to extend device operation time inside the body and reduce the necessity for high-risk repeated surgery. Without the technological innovation of in vivo energy harvesters driven by biomechanical energy, energy harvesters are insufficient and inconvenient to power titanium-packaged implantable medical devices. Here, we report on a commercial coin battery-sized high-performance inertia-driven triboelectric nanogenerator (I-TENG) based on body motion and gravity. We demonstrate that the enclosed five-stacked I-TENG converts mechanical energy into electricity at 4.9 μW/cm3 (root-mean-square output). In a preclinical test, we show that the device successfully harvests energy using real-time output voltage data monitored via Bluetooth and demonstrate the ability to charge a lithium-ion battery. Furthermore, we successfully integrate a cardiac pacemaker with the I-TENG, and confirm the ventricle pacing and sensing operation mode of the self-rechargeable cardiac pacemaker system. This proof-of-concept device may lead to the development of new self-rechargeable implantable medical devices.


Author(s):  
Lukas Winter ◽  
Ruben Pellicer-Guridi ◽  
Lionel Broche ◽  
Simone A. Winkler ◽  
Henning M. Reimann ◽  
...  

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